The paradigm shift from cytotoxic drugs to targeted treatments including small molecules, monoclonal antibodies and immune therapies necessitates a similar shake up in the regulation and funding of cancer biomarkers.
According to a report from the University of South Australia’s Sansom Institute for Health Research, capitalising on the opportunities that come with targeted therapies has to include more of a focus on the ‘target’.
“The processes must ensure that development and funding of the biomarker tests occurs simultaneously with therapy development so that the therapy can be specifically targeted at the appropriate population.”
Professor Ian Olver, co-author of Cancer Biomarkers in Australia and Sansom Institute director, told the limbic attempts to align the regulation of biomarkers via MSAC and targeted therapies via the PBAC had been inadequate.
He said cancer medicines matched to a biomarker test were taking about twice as long to be approved as cancer medicines without a biomarker.
A single agency approval process was one of the ways forward.
“Targeted therapies are a great advance but to make the best use of them we have to enrich the population likely to respond through the use of biomarkers.”
“It’s not an exaggeration to say that biomarkers are the silver bullet that can speed up diagnosis and pinpoint the best treatment approach for the patient, maximising the response while minimising toxicities,” he said.
The report also called for adaptive clinical trials design including the use of biomarkers as surrogate endpoints.
“If we choose a good end point, we can get the answers to research questions much quicker and that’s particularly important in areas of need where there aren’t many treatments.”
“When I was practicing, I did more negative studies in melanoma than anyone. The only cytotoxic had little effect; now we have third line treatments for melanoma.”
Professor Olver said he looked forward to seeing similar advances in ‘other untreatable cancers’ such as pancreatic cancer.
“We can balance the accelerated approvals of drugs with the potential increased risk of undetected toxicities with continuous post-approval surveillance,” he added.
Professor Olver said more ‘risk sharing’ was an option for funding biomarker tests.
“Big pharma will benefit from the development of biomarkers and has a role in funding the trials to demonstrate their validity. The question is should they also have a role in partly subsidising the costs of biomarker tests.”
The report also includes a comprehensive review of predictive, diagnostic and prognostic biomarkers across nine solid tumours.
A survey of oncologists and researchers which was also included in the report identified lung, pancreatic, breast, prostate, colorectal and ovarian cancer as the priority areas for biomarker development.